PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

NCT05215613 | Completed Results

• 1 other identifier: MDRG2017-89MS-158T
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.

Conditions

Proximal Humeral Fracture; Proximal Tibia Fractures; Diaphyseal Fracture

Keywords

Medical device; Performance; Safety; Clinical benefits; Diaphysis; Proximal humerus; Proximal Tibia; Fracture; Post Market Clinical Follow Up Study

Outcome Measures

Primary Outcomes (1)

• Performance: Fracture Healing

  Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.

  At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.

Secondary Outcomes (4)

• Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)

  At operative evaluation, immediate post-operative evaluation, last consultation visit at minimum 6 months post-operative and at the follow-up phone call at minimum 1 year postoperative.

• Tegner Lysholm Knee Score (Proximal Tibia)

  Final follow-up visit at minimum 1 year postoperative.

• Oxford Shoulder Score (OSS) (Proximal Humerus)

  Final follow-up visit at minimum 1 year postoperative.

• EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)

  Final follow-up visit at minimum 1 year postoperative.

Study Arms (1)

Patients implanted with the Zimmer® Plates and Screws System

Patients who already received the Zimmer® Plates and Screws System in the Diaphysis, Proximal Humerus and Proximal Tibia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive series of cases implanted with plates and screws belonging to the Zimmer® Plates and Screws System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups.

You may not qualify if:

• Off-label use
• Patients under the age of 18
• Prisoners
• Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
• Infection
• Metal sensitivity or intolerance
• Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
• Sternal or spinal fractures
• Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
• Patients with inadequate soft tissue coverage at the implant site

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Shoulder Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries

Limitations and Caveats

A limitation to this study is its retrospective design. Due to this, no patients implanted with a Zimmer® Plates and Screws System plate in the proximal humerus could be enrolled in this study.

Results Point of Contact

• Title: Andrea Singer
• Organization: Zimmer Biomet

andrea.singer@zimmerbiomet.com

(0)79 318 06 55

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: March 15, 2023
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2024-11

Locations

IT (1)